The HEADWIND-Study

Insel Gruppe AG, University Hospital Bern

Status

Completed

Conditions

Diabetes Mellitus, Type 1

Diabetes

Treatments

Other: Controlled hypoglycaemic state while driving with a driving simulator

Study type

Interventional

Funder types

Other

Identifiers

NCT04035993

HEADWIND

Details and patient eligibility

About

To analyse driving behavior of individuals with type 1 diabetes in eu- and progressive hypoglycaemia using a validated research driving simulator. Based on the driving variables provided by the simulator the investigators aim at establishing algorithms capable of discriminating eu- and hypoglycemic driving patterns using machine learning neural networks (deep machine learning classifiers).

Full description

Hypoglycaemia is among the most relevant acute complications of diabetes mellitus. During hypoglycaemia physical, psychomotor, executive and cognitive function significantly deteriorate. These are important prerequisites for safe driving. Accordingly, hypoglycaemia has consistently been shown to be associated with an increased risk of driving accidents and is, therefore, regarded as one of the relevant factors in traffic safety. Despite important developments in the field of diabetes technology, the problem of hypoglycaemia during driving persists. Automotive technology is highly dynamic, and fully autonomous driving might, in the end, resolve the issue of hypoglycemia-induced accidents. However, autonomous driving (level 4 or 5) is likely to be broadly available only to a substantially later time point than previously thought due to increasing concerns of safety associated with this technology. Therefore, solutions bridging the upcoming period by more rapidly and directly addressing the problem of hypoglycemia-associated traffic incidents are urgently needed.

On the supposition that driving behaviour differs significantly between euglycaemic state and hypoglycaemic state, the investigators assume that different driving patterns in hypoglycemia compared to euglycemia can be used to generate hypoglycemia detection models using machine learning neural networks (deep machine learning classifiers).

Enrollment

26 patients

Sex

All

Ages

21 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Informed Consent as documented by signature (Appendix Informed Consent Form)
DM1 as defined by WHO for at least 1 year or is confirmed C-peptide negative (<100pmol/l with concomitant blood glucose >4 mmol/l)
Subjects aged between 21-50 years
HbA1c ≤ 8.5 % based on analysis from central laboratory
Functional insulin treatment with insulin pump therapy (CSII) or basis-bolus insulin for at least 3 months with good knowledge of insulin self-management
Only for the main-study: Passed driver's examination at least 3 years before study inclusion. Possession of a valid Swiss driver's license. Active driving in the last 6 months before the study.

Exclusion criteria

Contraindications to the drug used to induce hypoglycaemia (insulin aspart), known hypersensitivity or allergy to the adhesive patch used to attach the glucose sensor
Women who are pregnant or breastfeeding
Intention to become pregnant during the study
Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases.
Other clinically significant concomitant disease states as judged by the investigator (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.)
Known or suspected non-compliance, drug or alcohol abuse
Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
Participation in another study with an investigational drug within the 30 days preceding and during the present study
Previous enrolment into the current study
Enrolment of the investigator, his/her family members, employees and other dependent persons
Total daily insulin dose >2 IU/kg/day.
Specific concomitant therapy washout requirements prior to and/or during study participation
Physical or psychological disease is likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator (especially coronary heart disease or epilepsy).
Current treatment with drugs known to interfere with metabolism (e.g. systemic corticosteroids, statins etc.) or driving performance (e.g. opioids, benzodiazepines)
Only for the main-study: Patients not capable of driving with the driving simulator or patients experiencing motion sickness during the simulator test driving session (at visit 2).